Documento fuente o registro público

FDA 510(k) K260755 — OptraSCAN System

FDA 510(k) index record K260755. Device: OptraSCAN System. Applicant as listed: Optrascan, Inc.. Decision date: 2026-07-02.

OtherU.S. Food and Drug Administration (FDA)2026-07-02

Fuente

"device_name": "OptraSCAN System"
api.fda.gov · Consultado el 2026-10-21

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

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Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-22

Disclaimer

professional use

References

FDA 510(k) public index record K260755.

Device name: OptraSCAN System. Applicant as listed: Optrascan, Inc..

Decision date: 2026-07-02. Decision wording: Substantially Equivalent.

Product code: NOT. Regulation: 21 CFR 864.1860. Medical specialty: Hematology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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FDA 510(k) K260755 — OptraSCAN System

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